An interventional study of Direct cortical stimulation and deep brain stimulation of motor thalamus in Movement Disorders (Incl Parkinsonism), Stroke and Traumatic Brain Injury, sponsored by Jorge Gonzalez-Martinez. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Jorge Gonzalez-Martinez · Not applicable, Interventional, and Basic science
In this study the investigators aim to enroll patients scheduled to undergo deep brain stimulation (DBS) implantation for movement disorders for intra-operative testing. In addition to standard-of-care surgical procedure to implant deep brain stimulation electrode leads, participants will also be stimulated and recorded from cortical areas by a temporary strip electrode (1X6) in the subdural space. The electrodes will be connected to external stimulators and a series of experiments will be performed to assess effects of the DBS on movement quality and electrophysiology measures. Results of this study will elucidate the biological mechanisms related to deep brain stimulation in modulating motor and speech function in patients with abnormal movement disorders.
In this study the investigators aim to enroll patients for intra-operative testing. Specifically, the investigators will recruit patients already undergoing DBS implantation for movement disorders. In addition to standard-of-care subcortical mapping using micro-electrode recording (MER) and macro-stimulation mapping during DBS placement, cortical local field potentials (LFPs) will be simultaneously recorded from primary motor (M1) and somatosensory (S1) cortical areas by placement of a temporary strip electrode (1X6) in the subdural space. Appropriate localization of this grid over M1 and S1 will be confirmed by the so-called phase-reversal of somatosensory evoked potentials (SSEPs). Once M1 is localized, the strip electrode over M1 will be used to produce motor evoked potentials to contralateral hand muscles from direct cortical stimulation (DCMEPs). The stimulation threshold of the DCMEPs will be used as a direct measure of the excitability of the cortical spinal tract and compared with and without stimulation of the VOP/VIM nuclei. Cortical and subcortical LFPs will be obtained alongside electromyographic (EMG) data while the patient performs contralateral upper extremity movement tasks measuring velocity, grip strength, and strength modulation and while the patient perform a variety of articulation exercises. Along with the DCMEP stimulation thresholds, these parameters of motor output will be obtained both with and without VOP/VIM stimulation to assess for stimulation induced potentiation of motor output.
371 studies on the registry are indexed under Movement Disorders; 102 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 221 interventional studies indexed under Movement Disorders.
Browse Movement Disorders studies →Jorge Gonzalez-Martinez is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment.
Exclusion Criteria:
Individuals undergoing deep brain stimulation device implanted in the motor thalamus for movement disorders treatment. Some of whom may also sustain speech, swallowing, and motor deficits.
Device: Direct cortical stimulation and deep brain stimulation of motor thalamus
All participants enrolled will undergo implantation of deep brain stimulation electrode leads for treatment of movement disorders. In addition to standard-of-care subcortical mapping using micro-electrode recording (MER) and macrostimulation mapping during DBS placement, cortical local field potentials (LFPs) will be simultaneously recorded from primary motor (M1) and somatosensory (S1) cortical areas by placement of a temporary strip electrode (1X6) in the subdural space. The strip electrode over M1 will be used to produce motor evoked potentials to contralateral hand muscles from direct cortical stimulation (DCMEPs). Cortical and subcortical LFPs will be obtained alongside electromyographic (EMG) data while the patient performs contralateral upper extremity movement tasks and a variety of articulation exercises.
Electromyography Activity
The investigators will record electromyography activity (EMG) to measure the motor evoked potentials of upper limb and facial muscles. At the end of the procedures these needles and/or the superficial adhesive electrodes will be removed. Based on the preliminary data, the investigators will consider the number of participants with at least an 18% increase in muscle activation as minimally acceptable.
Time frame: 14 days
Facial Muscle Motor Function - Muscle Strength
The investigators will use electromyography (EMG) testing to measure muscle strength produced by the subject during isometric facial movements (e.g. smile, tongue out, puckered lips, and open-close mouth). Amplitude of movement will be calculated by Area-Under-the-Curve with units of uV\^2/ms. Based on the preliminary data, the investigators will consider the number of participants with an increase of 50% in ROM as a minimally acceptable improvement in muscle strength.
Time frame: 14 days
Facial Muscle Motor Function - Range of Motion
The investigators will use electromyography (EMG) testing to measure range of motion produced by the subject during isometric facial movements (e.g. smile, tongue out, puckered lips, and open-close mouth). Based on the preliminary data, the investigators will consider the number of participants with an increase of 50% in ROM as a minimally acceptable improvement.
Time frame: 14 days
Speech Intelligibility
The investigators will use the Assessment of Intelligibility of Dysarthric Speech (AIDS) to assess the quality of communication and intelligibility of speech at both word- and sentence-level. Intelligibility is calculated as the percentage of words correctly identified in the single-word task, and as the percentage of correctly transcribed words and speech rate (in words per minute) in the sentence task. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 5% correctly transcribed to be minimally acceptable.
Time frame: 14 days
Dexterity of Articulation AMRs
The investigators will measure dexterity of articulation by alternating motion rates (AMRs) of the repetitive plosive sound (pah, tah, and kah). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Time frame: 14 days
Dexterity of Articulation SMRs
The investigators will measure dexterity of articulation by sequential motion rates (SMRs) of the repetitive plosive sound (pah, tah, and kah). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Time frame: 14 days
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will become available at the end of the trial upon publication of the first manuscript. Estimation is 7 years from enrollment of the first participant.
Access criteria: Data must be directly requested from the PI and will be shared upon completion of the necessary data-sharing agreement to protect confidential patient information.
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Dec 2026, 48 months after the start.
Of 83 non-industry interventional studies with no phase under Movement Disorders, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 80. This study's planned 48 months is above that.
Counting every sponsor, half of 85 studies reached it within 33 months; a quarter within 11 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
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Jorge Gonzalez-Martinez